Leica Biosystems

Primary DI
00849832002949
Brand
Leica Biosystems
Company
Leica Biosystems Richmond, Inc.
Model
000000000003803100
Device description
Frostbite
Published
2024-12-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
LEAPRESERVATIVE, CYTOLOGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LEAPreservative, CytologicalPathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10849832002946PrimaryGS10
00849832002949Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084983200294610849832002946
00849832002949008498320029498498320029490849832002949

GMDN Terms#

Term, Definition table
TermDefinition
Histology tissue cassette IVD, laboratory processing, single-useA small device intended to be used in the laboratory to support/contain clinical tissue specimens (e.g., biopsy samples) to facilitate specimen processing [e.g., fixation (encapsulation in paraffin wax), dehydration, infiltration] in preparation for subsequent cytological or histological examination, and storage. It is in the form of a plastic container, with or without a lid, with drainage holes to maximize fluid exposure during tissue submersion in a parent device into which the container is loaded. It may, in addition, include a fenestrated insert to hold and prevent the loss of a smaller specimens. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(866)4783999tech.support@Leicabiosystems.com

Regulatory Flags#

DUNS number
082930884
Device count
6
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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00849832007937Leica Biosystems Ariol UPS 110V23UPS22072016-09-17
00849832007944Leica Biosystems Ariol UPS 220V23UPS22082016-09-17
00849832009504Leica Biosystems Ariol MSCOPE Leica DM6000B BZ03 Ariol Multibay23MIC60042016-09-17
00849832009511Leica Biosystems Ariol Leica DM6000B Ariol23MIC60052016-09-17
00849832010333Leica Biosystems Ariol DM6000 B Basic Configuration Ariol23MIC12012016-09-17
00849832010340Leica Biosystems Ariol DM6000 B Basic Configuration Ariol Refurbished23MIC1201R2016-09-17
00849832010418Leica Biosystems Ariol DM6000 B Ariol PL20023MIC12062016-09-17
00849832010425Leica Biosystems Ariol DM6000 B for Ariol PL200 Refurbished23MIC1206R2016-09-17
00849832011361Leica Biosystems Ariol Beveled Edge Slide Holder23ASLSP0162016-12-02
00849832011576Leica Biosystems Ariol Cable, stage sensor23ASLSP0302017-03-29
00849832013204Leica ADAPTOR C14 TO C7, POWER SUPPLY23ADP00022017-10-13
00849832013228Leica Biosystems Slide Cassettes, SL20023ASLSP0032017-11-17

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Primary DI, Brand, Company table
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